An Overview of the Medical Devices Single Audit Program

Transcription

1 Your health and safety our priority. Votre santé et votre sécurité notre priorité. An Overview of the Medical Devices Single Audit Program Nancy Shadeed Bureau of Policy, Science and International Programs Therapeutic Products Directorate Health Canada

2 Medical Device Single Audit Program (MDSAP) The International Medical Device Regulators Forum (IMDRF) recognizes the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices. This global approach included the development of an international coalition of countries dedicated to pooling technology, resources, and services to improve the safety and oversight of medical devices on an international scale in a Pilot Program starting in January

3 Medical Device Single Audit Program (MDSAP) Vision: To develop, manage and oversee a single audit program that will allow a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions Long term goal: international coalition of countries dedicated to pooling technology, resources and services to improve safety and oversight of medical devices in a more efficient manner that is also less burdensome for industry Modelled after Health Canada s CMDCAS third party program; draws upon best practices of Canadian and American systems FDA, Health Canada, Therapeutics Goods Administration (Australia) and ANVISA (Brazil) signed a Statement of Cooperation (November 2012) to commit to the development and operation of this program. 3

4 Medical Device Single Audit Program (MDSAP) To enable the appropriate regulatory oversight of medical device manufacturers quality management systems while minimizing regulatory burden on industry. To promote, in the longer term, greater alignment of regulatory approaches and technical requirements globally based on international standards and best practices To promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority. 4

5 Pilot International Coalition The international coalition of countries for the MDSAP Pilot Program are: - Therapeutic Goods Administration (TGA) of Australia, - Brazil s Agência Nacional de Vigilância Sanitária (ANVISA), - Health Canada, and - U.S. Food and Drug Administration * Japan s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are official observers. 5

6 MDSAP - Elements Initial Recognition, Surveillance, and Re-Recognition Criteria for MDSAP Recognized Auditing Organizations (IMDRF Lead) Standardized Recognized AO Auditor Competency and Competency Maintenance Requirements (IMDRF Lead) Standardized Regulatory Authority Assessor Competency and Competency Maintenance Requirements (IMDRF Lead). Standardized Audit and Assessment Models Auditing of a Manufacturer by an MDSAP Recognized AO Assessment of MDSAP Recognized AO s by participating Regulatory Authorities 6

7 MDSAP - Elements Standardized Rating System for Manufacturer Audit Findings Standardized Rating System for Recognized Auditing Organization Assessment Findings MDSAP Quality Management System 7

8 MDSAP Manufacturer Audit Criteria ISO 13485: Specific Requirements of: TGA ANVISA HC FDA = One Comprehensive Audit Model 8

9 IMDRF-Medical Device Single Audit Program (MDSAP) As part of the MDSAP application process, the Auditing Organizations will have to comply with the following IMDRF MDSAP document in addition to other documents approved by the Pilot Coalition Regulatory Authority Council: - IMDRF MDSAP WG N3 Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - IMDRF MDSAP WG N4 Competency and Training Requirements for Auditing Organizations 9

10 IMDRF Medical Device Single Audit Program (MDSAP) IMDRF MDSAP WG N3 Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition and IMDRF MDSAP WG N4 Competence and Training Requirements for Auditing Organizations, are complementary documents. These two documents N3 and N4 are focused on requirements for an Auditing Organization and individuals performing regulatory audits and other related functions under the respective medical device legislation, regulations, and procedures required in its regulatory jurisdiction. 10

11 IMDRF Medical Device Single Audit Program (MDSAP) IMDRF MDSAP WG N5 Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations and IMDRF MDSAP WG N6 - Regulatory Authority Assessor Competence and Training Requirements, are complementary documents. These two documents N5 and N6 are focused on how Regulatory Authorities and their assessors will evaluate or assess medical device Auditing Organizations compliance to the requirements in the IMDRF MDSAP N3 and N4 documents. 11

12 IMDRF Medical Device Single Audit Program (MDSAP) In addition, IMDRF WG N11 MDSAP Assessment Outcomes and Recognition/Rerecognition Decision by Regulatory Authorities is currently out for public comment This document describes the grading of nonconformities resulting from a Regulatory Authority Assessment of an Auditing Organization and to document the decision process for recognizing an Auditing Organization or ceasing recognition. 12

13 What oversight will Regulatory Authorities have over the Auditing Organizations? In accordance with best practices, the Regulatory Authorities involved in the Pilot Coalition have developed a robust plan and schedule of assessing the competence and compliance of MDSAP Auditing Organizations to include headquarter office assessments, witnessed audits, and critical site location assessments on an annual basis as part of a four year recognition process. 13

14 MDSAP- Four Year Auditing Organization Recognition Cycle 14

15 MDSAP Manufacturer Audit Cycle The Medical Device Single Audit Program is based on a three (3) year audit cycle. The Initial Audit, also referred to as the Initial Certification Audit is a complete audit of a medical device manufacturer s quality management system (QMS) consisting of a Stage 1 Audit and a Stage 2 Audit. 15

16 MDSAP Manufacturer Audit Cycle The initial Audit is followed by a partial Surveillance Audit in each of the following two (2) years and a complete Re-audit, also referred to as a Recertification Audit in the third (3rd) year. Special Audits, Audits Conducted by Regulatory Authorities, and Unannounced Audits are potential extraordinary audits that may occur at any time within the audit cycle. 16

17 MDSAP Pilot A jointly prepared Statement on the launch of the pilot was posted on individual agency websites in October Joint Statement outlines how each regulatory authority will utilize the single audit program and the resulting audit report/certificate During the pilot, the 14 auditing organizations currently recognized under CMDCAS are eligible for application to be assessed under MDSAP pilot starting January This list can be found at: 17

18 MDSAP Pilot The MDSAP project plan targets the review of applications every six months for the duration of the pilot. Anticipate that auditing organizations will be ready to conduct MDSAP audits by later this year.. 18

19 Documents, policies, procedures that will be utilized in the MDSAP Pilot Also, there are many other MDSAP Regulatory Authority Council reviewed and approved documents for implementing the pilot to include the audit strategy for auditing medical device manufacturers such as: requirements for the audit reports, audit time calculations, MDSAP Quality Management System procedures, etc. These documents can be found at: DSAPPilot/ucm htm 19

20 HC Considerations during the Pilot HC must run two programs (CMDCAS and MDSAP) in parallel during the 3 year pilot This raises a number of issues including: Potential for overlapping oversight of registrars by SCC and MDSAP Regulatory Authorities Issuance of certificates under an MDSAP audit Reporting and resource requirements Health Canada committed to working with the SCC to minimize burden on registrars Health Canada also committed to avoiding any burden on industry as a result of running both programs 20

21 HC Considerations: Implementation Upon the successful conclusion of the pilot, Health Canada's intent is to implement MDSAP as the mechanism to achieve regulatory compliance for quality management system requirements in Canada MDSAP would therefore replace the CMDCAS program, regardless of whether a manufacturer intends to market only in Canada (in which case only HC specific regulatory requirements would be assessed for the purposes of issuing a certificate) Transition strategy from CMDCAS to MDSAP under development 21

22 Summary While Health Canada has implemented a respected third party auditing program, MDSAP will improve our system as a result of Increased regulatory oversight of third party Auditing Organizations More robust and internationally consistent audit processes Increased definition of expected auditor competencies A robust MDSAP database and information management system In sum, MDSAP represents the future of international regulatory programs: stronger and more effective than the sum parts while less burdensome for industry 22

23 MDSAP Pilot Volunteer to participate! Be a part of the process during the pilot to help shape the policies and procedures for the operational program scheduled to being in Contact your current auditing organization to see how you can participate in the pilot. 23